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Resources
Updates and resources related to digital documentation for medical devices and IVDs
Press Announcement
In Vitro Diagnostic Regulation
Webinars
Medical Device Regulation
Medical Device Regulation
Why we should take MDR and IVDR GSPR into focus
In Vitro Diagnostic Regulation
IVDR Risk Classification demystified!
In Vitro Diagnostic Regulation
Technical Documentation under IVDR: A Comprehensive Guide & Free Download
Webinars
PODCAST - Embracing Digitalization in Regulatory Affairs: A Conversation with Dr. Bassil Akra and Michael Kania
Medical Device Regulation
MDR Labeling - Explained!
Webinars
How to manage Technical Documentation in the most efficient way?
Medical Device Regulation
Überprüfungen von Klasse I Herstellern durch Behörden laufen vermehrt an. Was derzeit passiert und was man unbedingt beachten sollte.
Medical Device Regulation
Digitalization of QA RA
Medical Device Regulation
Interview: Regulatory 4.0
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